CLINICAL TRIALS PROFILE FOR COLESTIPOL HYDROCHLORIDE

All Clinical Trials for COLESTIPOL HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00203476 ↗	A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction	Completed	American Society of Health-System Pharmacists Research and Education Foundation	Phase 4	2005-05-01	To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
NCT00203476 ↗	A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction	Completed	Tuscaloosa Research & Education Advancement Corporation	Phase 4	2005-05-01	To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
NCT00307307 ↗	Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.	Completed	Kos Pharmaceuticals	Phase 4	2000-01-01	The primary objective of this randomized, double blind, placebo controlled pilot study is to determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhibitor - simvastatin) or increasing HDL cholesterol (Niaspan) will induce regression of carotid atherosclerotic plaque in vivo using MRI imaging techniques. MR plaque morphology at baseline will be compared to that after 6 and 12 months of therapy and changes in MR characteristics will be compared to changes in lipoprotein parameters and urinary isoprostanes. The effect of moderate LDL reduction, aggressive LDL reduction and the combination of aggressive LDL reduction and HDL elevation on MRI plaque characteristics will be compared by randomly assigning subjects (n=69) with carotid disease (>30% stenosis by ultrasound criteria) to one of three treatment arms; 1. Simvastatin 20 mg daily and placebo Niaspan (n=23) 2. Simvastatin 80 mg daily and placebo Niaspan (n=23) 3. Simvastatin 20 mg daily and active Niaspan (n=23) Treatment group 2 and 3 will have roughly equivalent LDL lowering because of the synergistic LDL lowering effect of the combination of simvastatin and Niaspan.
NCT00116870 ↗	MARS - Monitored Atherosclerosis Regression Study	Completed	Merck Sharp & Dohme Corp.	Phase 2/Phase 3	1985-06-01	The purpose of this study is to determine whether significant alterations in serum lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis progression or even induce regression.
NCT00000512 ↗	Familial Atherosclerosis Treatment Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-01-01	To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00000512 ↗	Familial Atherosclerosis Treatment Study	Completed	University of Washington	Phase 3	1984-01-01	To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00000599 ↗	Cholesterol-Lowering Atherosclerosis Study (CLAS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1980-06-01	To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride plus niacin would produce significant change in coronary, carotid, and femoral artery atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to determine possible correlations between lesion changes and plasma lipid and lipoprotein cholesterol levels and to explore interrelationships of atherosclerosis change in femoral, coronary, and carotid arteries.

Clinical Trial Conditions for COLESTIPOL HYDROCHLORIDE

Condition Name

Condition Name for COLESTIPOL HYDROCHLORIDE
Intervention	Trials
Coronary Disease	2
Myocardial Ischemia	2
Atherosclerosis	2
Cardiovascular Diseases	2

Condition MeSH

Condition MeSH for COLESTIPOL HYDROCHLORIDE
Intervention	Trials
Atherosclerosis	4
Myocardial Ischemia	3
Coronary Disease	3
Coronary Artery Disease	3

Clinical Trial Locations for COLESTIPOL HYDROCHLORIDE

Trials by Country

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−

Trials by Country for COLESTIPOL HYDROCHLORIDE
Location	Trials
United States	25
Australia	3
Canada	2
Germany	1
France	1

Trials by US State

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−

Trials by US State for COLESTIPOL HYDROCHLORIDE
Location	Trials
Missouri	2
Alabama	2
California	2
Florida	2
Massachusetts	1

Clinical Trial Progress for COLESTIPOL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for COLESTIPOL HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for COLESTIPOL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	8
Enrolling by invitation	1
Terminated	1

Clinical Trial Sponsors for COLESTIPOL HYDROCHLORIDE

Sponsor Name

Sponsor Name for COLESTIPOL HYDROCHLORIDE
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
Merck Sharp & Dohme Corp.	2
Brigham and Women's Hospital	1

Sponsor Type

Sponsor Type for COLESTIPOL HYDROCHLORIDE
Sponsor	Trials
Other	12
Industry	6
NIH	2

Colestipol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Colestipol hydrochloride is a bile acid sequestrant used primarily to lower cholesterol levels and reduce the risk of cardiovascular diseases. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Mechanism of Action

Colestipol hydrochloride works by binding to bile acids in the intestine, which are then excreted in the feces. This process increases the oxidation of cholesterol to bile acids, leading to an increase in the number of LDL receptors, enhanced hepatic uptake of LDL, and a subsequent decrease in serum cholesterol levels[4].

Clinical Trial Outcomes

In a randomized study involving 66 hypercholesterolemic patients, dosages of 10 g of colestipol HCl twice daily resulted in a 19% reduction in serum cholesterol levels compared to placebo therapy. This reduction is comparable to other studies where the same total daily dose was administered in three or four doses. The most common side effect reported was constipation, but no significant systemic reactions or abnormal laboratory data were observed[1].

A large, placebo-controlled study (LRC-CPPT) involving cholestyramine, another bile-acid sequestrant with a similar mechanism to colestipol hydrochloride, showed a 19% reduction in the combined rate of coronary heart disease death plus non-fatal myocardial infarction over a seven-year period. Although this study was not specifically on colestipol hydrochloride, it underscores the efficacy of bile acid sequestrants in reducing cardiovascular risks[4].

Market Analysis

Market Size and Growth

The Colestipol Hydrochloride market has experienced significant growth and is projected to continue this trend. As of 2023, the market size was valued at $1000.1 million and is expected to reach $1621.1 million by 2030, growing at a CAGR of 7.1%[5].

Market Segmentation

The market is segmented based on type (≥99% Purity, Other), application (Anti Hyperlipoproteinemic, Other), and geography (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). Key players in the market include Medilux Laboratories, THINQ Pharma-CRO, and Formosa Laboratories[2][5].

Market Drivers

Several factors drive the growth of the Colestipol Hydrochloride market:

• Rising Prevalence of Hypercholesterolemia: The increasing incidence of hypercholesterolemia, driven by sedentary lifestyles and dietary habits, fuels the demand for cholesterol-lowering agents[3].
• Efficacy in Cardiovascular Risk Reduction: Colestipol Hydrochloride’s proven efficacy in reducing LDL cholesterol levels and mitigating cardiovascular risks makes it a preferred therapeutic option[3].
• Increasing Focus on Preventive Healthcare: Growing awareness about preventive healthcare measures boosts demand for pharmaceutical interventions like Colestipol Hydrochloride[3].
• Technological Advancements: Innovations in drug formulation technologies enhance the efficacy, safety, and patient compliance of Colestipol Hydrochloride[3].

Market Challenges

Despite the growth, the market faces several challenges:

• Adverse Effects: Gastrointestinal discomfort and other tolerability concerns are significant drawbacks[3].
• Intense Competition: The presence of alternative cholesterol-lowering therapies poses a competitive threat[3].
• Regulatory Hurdles: Stringent regulatory mandates and approval processes can slow market entry and expansion[3].

Market Projections

Forecast Period

The market is expected to see robust growth from 2023 to 2031, driven by the escalating prevalence of hypercholesterolemia and the increasing focus on preventive healthcare. The forecast period indicates continued significant expansion, with the market set for notable development[2][3].

Geographic Expansion

Geographic expansion into untapped markets, particularly in emerging economies, presents a significant opportunity for growth. The Asia-Pacific region is expected to be a key area for expansion due to its large population and growing healthcare needs[3].

Technological Innovations

Ongoing innovations in formulation and drug delivery technologies will enhance the efficacy, safety, and patient compliance of Colestipol Hydrochloride. This includes the integration of digital health technologies for remote patient monitoring and adherence support[3].

Regulatory Harmonization

Harmonization of regulatory standards and expedited approval pathways will accelerate market entry for Colestipol Hydrochloride generics and biosimilars, fostering market competition and affordability[3].

SWOT Analysis

Strengths

• Established Therapeutic Efficacy: Colestipol Hydrochloride has a well-documented efficacy in managing hypercholesterolemia and reducing cardiovascular risks.
• Favorable Safety Profile: The drug has a favorable safety profile and tolerability, although gastrointestinal side effects are common.
• Growing Disease Awareness: Increasing awareness about hypercholesterolemia and the importance of cholesterol management drives demand[3].

Weaknesses

• Adverse Effects: Gastrointestinal discomfort and other tolerability concerns are significant drawbacks.
• Limited Market Penetration: The drug has limited market penetration beyond niche demographics.
• Intense Competition: The presence of alternative cholesterol-lowering therapies poses a competitive threat[3].

Opportunities

• Expansion of Indications: Potential expansion of indications beyond hypercholesterolemia.
• Technological Innovations: Innovations in formulation and drug delivery technologies.
• Geographic Expansion: Expansion into untapped markets, particularly in emerging economies[3].

Threats

• Regulatory Hurdles: Stringent regulatory mandates and approval processes.
• Market Competition: Increasing competition from alternative therapies and biosimilars[3].

Key Takeaways

• Colestipol Hydrochloride is a bile acid sequestrant with proven efficacy in reducing serum cholesterol levels and mitigating cardiovascular risks.
• The market for Colestipol Hydrochloride is growing, driven by the rising prevalence of hypercholesterolemia and increasing focus on preventive healthcare.
• Technological innovations and geographic expansion are key opportunities for market growth.
• Despite its strengths, the market faces challenges such as adverse effects, intense competition, and regulatory hurdles.

FAQs

What is the primary mechanism of action of Colestipol Hydrochloride?

Colestipol Hydrochloride works by binding to bile acids in the intestine, leading to their excretion and an increase in the oxidation of cholesterol to bile acids, which in turn reduces serum cholesterol levels[4].

What are the common side effects of Colestipol Hydrochloride?

The most common side effect reported is constipation, although other gastrointestinal discomforts can also occur[1].

What is the projected market size of Colestipol Hydrochloride by 2030?

The market size is expected to reach $1621.1 million by 2030, growing at a CAGR of 7.1% from 2023[5].

Which regions are expected to drive the growth of the Colestipol Hydrochloride market?

The Asia-Pacific region, along with other emerging economies, is expected to be a key area for market expansion due to growing healthcare needs and large populations[3].

How does Colestipol Hydrochloride impact cardiovascular risk?

Colestipol Hydrochloride reduces LDL cholesterol levels and mitigates cardiovascular risks, as evidenced by studies showing a reduction in the combined rate of coronary heart disease death plus non-fatal myocardial infarction[4].

Sources

1. Cholesterol-lowering effect of colestipol hydrochloride given twice daily - PubMed
2. Colestipol Hydrochloride Market Size, Scope And Forecast Report - Market Research Intellect
3. Colestipol Hydrochloride Market 2024-2032 | Size, Share, Growth - MarkWide Research
4. COLESTID ® GRANULES Clinical Pharmacology - Pfizer Medical Information
5. Colestipol HCl Market Size, Share, Growth | Global Industry Trends - Verified Market Reports